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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031977
Receipt No. R000036365
Scientific Title Evaluation of improving effects on fasting blood glucose of the test food.
Date of disclosure of the study information 2018/04/02
Last modified on 2018/08/09

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Basic information
Public title Evaluation of improving effects on fasting blood glucose of the test food.
Acronym Evaluation of improving effects on fasting blood glucose of the test food.
Scientific Title Evaluation of improving effects on fasting blood glucose of the test food.
Scientific Title:Acronym Evaluation of improving effects on fasting blood glucose of the test food.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines improving effects on fasting blood glucose of the test food for 12weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fasting blood glucose
Key secondary outcomes Immunoreactive insulin,
Homeostasis model assessment of insulin resistance,
Incremental blood glucose area under the curve.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of 4 packages of the test food per day for 12 weeks.
Interventions/Control_2 Intake of 4 packages of the placebo food per day for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria (1)Aged between 20 and 59 years old at consent acquisition.
(2)Subjects whose fasting blood glucose is 100-125 mg/dL or whose blood glucose is 140-199mg/dL (at 120 minutes of glucose tolerance test).
(3)Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria (1)Subjects using medical products.
(2)Subjects who have a habit of ingesting medicine, health-promoting foods, foods for specified health uses, health foods that may affect this study.
(3)Females who are pregnant or lactating, or who could become pregnant or lactating during test period.
(4)Subjects who have a history of heart failure,liver failure, kidney failure, or digestive system disease.
(5)Subjects who excessively take alcohol.
(6)Subjects whose eating habits and rhythm of daily life are irregular (Shifts workers, late-night workers).
(7)Subjects who have allergy for medicine and foods.
(8) Subjects who are participating in other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate in other clinical tests.
(9) Subjects who donated over 200mL blood and/or blood components within the last one month.
(10) Males who donated over 400mL blood within the last three months.
(11) Females who donated over 400mL blood within the last four months.
(12) Males who will be collected over 1200 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months.
(13) Females who will be collected over 800 mL of blood when the planned sampling volume in this study is added to the volume collected within the last 12 months.
(14)Subjects who are not eligible for this study for some medical reasons.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujiwara Suguru
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL 03-5297-3112
Email cpcc-contact@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ichinohe
Organization CPCC Company Limited
Division name Plan Sales Department
Zip code
Address 4F Chusin Builging, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Nisshin Seifun Group Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036365

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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